Visualization devices for use during percutaneous tissue dissection and associated systems and methods

ABSTRACT

A device and method for visualization of the intravascular creation of autologous valves, and particularly venous valve, is disclosed herein. One aspect of the present technology, for example, is directed toward a delivery catheter that can include a lumen configured to receive a dissection assembly and a trough having a plurality of transducers electrically coupled to a proximal portion of the delivery catheter. At least one of the transducers can be configured to emit a signal towards a portion of a blood vessel adjacent the trough, and at least one of the transducers can be configured to receive a reflection of the emitted signal.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 14/667,201 filed Mar. 24, 2015, which claims the benefit of U.S.Provisional Application No. 61/969,262, filed Mar. 24, 2014 and. U.S.Provisional Application No. 61/969,263, filed Mar. 24, 2014, thedisclosures of which are incorporated herein by reference in theirentireties.

TECHNICAL FIELD

The present technology relates generally to devices and methods forintravascular modification of body lumens. Many embodiments of thepresent technology relate to visualization devices, systems and methodsfor use during the intravascular creation of dissection pockets withinblood vessels.

BACKGROUND

Controlled dissection of a body lumen wall is a necessary treatmentcomponent of many widespread medical conditions. For example, in orderto bypass a chronic total occlusion (CTO) in the vascular system, thephysician can use a catheter to enter and travel through a length of theblood vessel wall corresponding to the site of the occlusion. As anotherexample, one course of treatment for venous reflux involves modificationof the blood vessel wall to create a valve and/or valve leaflet and/orrepair a faulty valve and/or valve leaflet. One method for autologouscreation of a valve leaflet, for instance, includes accessing thetreatment site (either surgically or intravascularly) and entering thevessel wall with a catheter to create a dissection pocket (e.g.,aportion of a body lumen wall where the wall has been separated into twoor more distinct layers) Depending on the procedure (e.g., bypassing aCTO, creating a leaflet, etc.), it can be advantageous to finely controlthe shape and size of the dissection pocket. Such control can bechallenging, especially considering the thinness and fragility of mostbody lumen walls, the curvature of most body lumen walls, the presenceof pathologic changes to body lumen walls, and the effects of local,dynamic blood flow. Accordingly, the devices, systems, and methods ofthe present technology address these challenges.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present technology can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure.

FIG. 1A is a perspective view of a delivery catheter in accordance withan embodiment of the present technology.

FIG. 1B is a side view of the delivery catheter of FIG. 1A in accordancewith an embodiment of the present technology.

FIG. 1C is a cross-sectional end view of the delivery catheter of FIGS.1A-1B taken along line 1C-1C in FIG. 1B.

FIG. 1D is an isolated top view of the trough of FIGS. 1A-1C inaccordance with an embodiment of the present technology.

FIGS. 2A-2C are cross-sectional end views of troughs in accordance withembodiments of the present technology.

FIG. 3A is a side view of a delivery catheter in accordance with anotherembodiment of the present technology shown along with to a dissectionassembly and a visualization device.

FIG. 3B is a cross-sectional end view of the treatment device of FIG. 3Ataken along line 3B-3B.

FIG. 4A is a schematic representation of a three-dimensional image of aportion of a blood vessel.

FIG. 4B is a schematic representation of generated images in accordancewith the present technology.

FIG. 4C is a schematic representation of an exemplary display screen inaccordance with the present technology.

FIG. 5 is a partial cross-sectional side view of a distal portion of adelivery catheter in accordance with an embodiment of the presenttechnology shown positioned within a blood vessel.

FIG. 6A is a top view of an expanded, semi-straightened pocket creationelement in accordance with an embodiment of the present technology.

FIG. 6B is an end view of a pocket creation balloon in an expanded,unobstructed state, in accordance with an embodiment of the presenttechnology.

DETAILED DESCRIPTION

The present technology provides devices, systems, and methods forintravascular tissue dissection, such as creating dissection pocketswithin the wall of a body lumen. Specific details of several embodimentsof treatment devices, systems and associated methods in accordance withthe present technology are described below with reference to FIGS.1A-6B. Although many of the embodiments are described below with respectto devices, systems, and methods for intravascular creation ofautologous venous valves and/or valve leaflets, other applications andother embodiments in addition to those described herein are within thescope of the technology. For example, the present technology can be usedin any body cavity or lumen or walls thereof (e.g., arterial bloodvessels, venous blood vessels, urological lumens, gastrointestinallumens, etc.), and for the surgical creation of autologous valves aswell as the repair of autologous and/or synthetic valves. Additionally,several other embodiments of the technology can have different states,components, or procedures than those described herein. Moreover, it willbe appreciated that specific elements, substructures, advantages, uses,and/or other features of the embodiments described with reference toFIGS. 1A-6B can be suitably interchanged, substituted or otherwiseconfigured with one another in accordance with additional embodiments ofthe present technology. For example, the transducer array described withreference to FIGS. 1A-1C and/or the trough geometries shown in FIGS.2A-2C can be combined with any of the delivery catheters and/orvisualization devices shown in FIGS. 3A-3B. Likewise, the pocketcreation element described in FIGS. 6A-6B can be combined with any ofthe delivery catheters described herein.

Furthermore, suitable elements of the embodiments described withreference to FIGS. 1A-6B can be used as standalone and/or self-containeddevices. A person of ordinary skill in the art, therefore, willaccordingly understand that the technology can have other embodimentswith additional elements, or the technology can have other embodimentswithout several of the features shown and described below with referenceto FIGS. 1A-6B. For example, the devices, systems, and methods of thepresent technology can be used with any of the catheter devices,systems, and methods disclosed in U.S. patent application Ser. No.13/035,752, filed Feb. 2, 2011; U.S. patent application Ser. No.13/035,818, filed Feb. 25, 2011; U.S. patent application Ser. No.13/450,432, filed Apr. 18, 2012; U.S. Provisional Patent Application No.61/969,262, filed Mar. 24, 2013; U.S. Provisional Patent Application No.61/969,263, filed Mar. 24, 2013; U.S. patent application Ser. No.13/926,886, filed Jun. 25, 2013; PCT Application No. PCT/US2014/011169,filed Jan. 10, 2014; U.S. patent application Ser. No. 14/377,492, filedAug. 7, 2014; U.S. patent application Ser. No. 14/498,969, filed Sep.26, 2014; and U.S. Provisional Patent Application No. 62/092,809, filedDec. 16, 2014, all of which are incorporated by reference herein intheir entireties (referred to collectively as “the Patents”).

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a delivery catheter and/or anassociated device with reference to an operator and/or a location in thevasculature.

FIG. 1A is a perspective view of a distal portion 100 of a deliverycatheter in accordance with an embodiment of the present technologyshown in an expanded state. A proximal portion (not shown) of thedelivery catheter is configured to be positioned external to the patientwhile the distal portion 100 of the delivery catheter is positionedintravasculady at a treatment site. FIG. 1B is a side view of the distalportion 100 in the expanded state and positioned within a blood vessel V(e.g., a vein), and FIG. 1C is a cross-sectional end view of the distalportion 100 of FIG. 1B taken along line 1C-1C. Referring to FIGS. 1A-1Ctogether, the delivery catheter can include a support 108, a devicelumen 110 (not shown in FIG. 1C), an expansion lumen 130 (FIG. 1C), anexpandable element 136 fluidly coupled to the expansion lumen 130, anopen trough 112, and a transducer array 111 in the trough 112. In someembodiments, the expandable element 136 can be a balloon. In otherembodiments, the expandable element 136 can be any expandable and/orinflatable structure (e.g., a wire cage, an expandable mesh, etc.).

The device lumen 110 is configured to slidably receive one or moreinterventional devices and extends distally from the proximal portion ofthe delivery catheter to an exit port 121 (FIG. 1A) positioned along aslanted surface 101 of the distal portion 100. For example, the devicelumen 110 is configured to slidably receive a dissection assembly (notshown) configured to dissect at least a portion of a length l (FIG. 1B)of the vessel wall VW adjacent the distal portion 100. In someembodiments, the surface 101 shown in FIGS. 1A-1B can have otherconfigurations. For example, in some embodiments the surface 101 can beperpendicular to a longitudinal axis of the delivery catheter and theexit port 121 can be positioned along the perpendicular surface.

The expansion lumen 130 can extend distally from the proximal portion ofthe delivery catheter to one or more transition elements (not shown)that are configured to fluidly couple the expansion lumen 130 to theexpandable element 136. For example, in embodiments where the expandableelement 136 is a balloon or similar inflatable structure, the expansionlumen 130 is fluidly coupled to the balloon via one or more inflationports (not shown). Additionally, the expandable element 136 ispositioned along the delivery catheter such that at least a portion ofthe expandable element 136 is circumferentially opposite a tissueengaging portion of the trough 112, as described in greater detailbelow. In the illustrated embodiment, the trough 112 has a main channel113 surrounded by a bottom portion 115 and sidewalls 109 that extendupwardly from the bottom portion 115 with tissue engaging portions 114along the sidewalls 109.

Referring to FIG. 1C, the transducer array 111 can include one or moretransmitting groups 116 and one or more receiving groups 118. Each ofthe transmitting groups 116 can comprise one or more transducers 117configured to transmit a signal (e.g., intravascular ultrasound (“IVUS”)transducers, optical coherence tomography (“OCT”) transducers, etc.),and each of the receiving groups 118 can comprise one or moretransducers 119 configured to receive a reflected signal (e.g., IVUStransducers, OCT transducers, etc.). As shown in FIG. 1C, in someembodiments the trough 112 can include an ultrasonic backing material122 adhered to the bottom portion 115, and the transducers 117, 119 canbe coupled or fixed to the ultrasonic backing material 122. Theindividual transmitting groups 116 and/or the receiving groups 118 caninclude from one transducer to over 100 transducers (e.g., 128transducers). Moreover, different transmitting groups can have differentnumbers of transducers, different receiving groups can have differentnumbers of receivers, and the transmitting groups 116 and the receivinggroups 118 can have the same number and/or different numbers oftransducers. In some embodiments, the trough 112 can include one or moretransducers (or group(s) of transducers) configured to both transmit andreceive signals.

The trough 112 and/or support 108 can include one or more channels 124extending therethrough that are configured to receive one or more wires126 extending distally from a proximal portion (not shown) of thedelivery catheter to the transducers 117, 119. In some embodiments, thewires 126 can be coupled to a handle assembly (not shown) and/or adisplay (not shown) coupled to a proximal portion of the deliverycatheter (e.g., directly via a cable and/or wirelessly via Bluetooth,radiofrequency (“RF”) signals, Wi-Fi, etc.). The handle assembly and/orthe display can include a controller having memory and processingcircuitry. The controller can be configured to activate the transducersto emit signals and process the received signals to generate an image onthe display and/or provide diagnostic or therapeutic information to theuser, as described in greater detail below with reference to FIGS.4A-5C.

FIG. 1D is an isolated top view of the trough 112. As shown in FIG. 1D,the transmitting groups 116 and the receiving groups 118 can be arrangedin adjacent transmitting and receiving columns C1, C2, respectively,that extend along the length L of the trough 112. In some embodiments,the transmitting column C1 can be spaced apart from the receiving columnC2 by a distance d of about 1 mm to about 10 mm. It will be appreciatedthat any arrangement and/or spacing of the transducers can be selecteddepending on the desired field of view. For example, the transmittinggroups 116, the receiving groups 118, and/or the transducers 117, 119can be sized and/or positioned along the trough 112 such that theindividual fields of view of the transducers 117, 119 overlap and/or areclose enough together such that the resulting images collectivelyrepresent an area of the vessel wall defined by the length L of thetrough 112 aligned with the channel 113, as well as the width W of thetrough 112. Although two columns and ten rows are shown in FIGS. 1A-1D,in other embodiments the trough 112 can have more or fewer columns(e.g., one column, three columns, four columns, etc.) and/or more orfewer rows (one row, five rows, 50 rows, 100 rows, etc.).

The trough 112 can be constructed from different materials depending onthe imaging modality used. In embodiments utilizing intravascularultrasound (“IVUS”) transducers, the trough 112 material can have a highporosity to absorb sound waves and prevent reflections that can distortthe image of the vessel wall VW (FIG. 1B). For example, the trough 112may be made from a porous or semi-porous material such as a ceramic or aporous polymer or plastic. In some embodiments, the trough 112 can bemade of one or more traditionally nonporous materials and be processedto have a predetermined porosity. For example, the trough 112 could bemade from a three-dimensional printed polyether ether ketone (“PEEK”)material or other plastic material that is built from layers depositedin a manner that leaves the material sufficiently porous. The trough 112may also absorb waves if the material includes one or more imperfectionsthat are smaller than the scale of the material, such as air bubbles, areflective surface configured to cause local scattering, and the like.For example, in some embodiments the trough can include silicone curedsuch that one or more air bubbles are suspended within the silicone.

In addition to the material of the trough 112, the shape of the trough112 can be selected to provide different acoustic properties. Forexample, FIGS. 2A-2C are cross-sectional end views of trough embodimentsconfigured in accordance with the present technology. The transducersare not shown in FIGS. 2A-2C for ease of illustration. FIG. 2A shows oneembodiment of a trough 210 having a curved inner surface at the bottomportion 212 and sidewalls 214. The inner surfaces of sidewalls 214 havea first linear section 216 extending upwardly from the bottom portion212 and a second linear section 218 extending upwardly from the firstlinear section 216 and positioned at an angle relative to the firstlinear section 216. In other embodiments, the first and second sections216, 218 can be linear, curved and/or have other suitableconfigurations. As shown in FIG. 2A, the second sections 218 can begenerally perpendicular to a plane P running parallel to the vessel wall(not shown) when engaged by the tissue engaging portions 220. Such aconfiguration can provide a more direct angle for the emitted signals(e.g., sound waves) near the tissue engaging portions 220 of the trough210, thereby providing a more distinct visual cue or landmark for theuser at the junction between the tissue engaging portions 220 and thesecond sections 218.

In some embodiments, the inner surfaces of the sidewalls can have agenerally continuous curved or linear configuration. For example, FIG.2B shows a trough 230 having a semi-elliptical shape. In otherembodiments, the trough 230 can have sidewalk with curved innersurfaces. In the embodiment of a trough 250 shown in FIG. 2C, the trough250 has a polygonal shape (e.g., a half-hexagon shape, a half-squareshape), etc. In other embodiments, the trough can have any suitableshape, size and/or configuration to improve the field of view andquality of the resulting image.

FIG. 3A is a side view of a distal portion 300 of another embodiment ofa delivery catheter in accordance with the present technology shown inan expanded state and positioned within a blood vessel V along with adissection assembly 380 and a visualization catheter 370. FIG. 3B is across-sectional end view of the distal portion 300 of FIG. 3A takenalong line 3B-3B. Referring to FIGS. 3A-3B together, the deliverycatheter of FIGS. 3A-3B can be generally similar to the deliverycatheter of FIGS. 1A-1D, except the delivery catheter of FIGS. 3A-3Bincludes a visualization lumen 321 configured to slidably receive avisualization catheter 370. The distal portion 300 can include an opentrough 312 having a channel 313 configured to slidably receive thevisualization catheter 370 therethrough. In the embodiment shown inFIGS. 3A-3B, the trough 312 does not include a transducer array. Inother embodiments, however, the trough 312 may include one or moretransducers.

The visualization catheter 370 can be an IVUS device, an OCT device, adirect visualization device and/or any other suitable visualizationdevice. The visualization lumen 321 can extend distally from theproximal portion (not shown) of the delivery catheter to an exit port atthe distal portion 300 that opens into the channel 313 of the trough312. Although the embodiment of the delivery catheter shown in FIGS.3A-3B does not include a guidewire lumen (and rather a guidewire 371 isfed through the visualization catheter 370), in other embodiments thetreatment device 300 can also include a guidewire lumen.

As shown in FIG. 3A, the visualization catheter 370 can be advancedthrough the trough 312 such that an imaging portion 372 of thevisualization catheter 370 is positioned distal to a distal terminus ofthe trough 312. In this “distal configuration,” the visualizationcatheter 370 and/or the imaging portion 372 can be configured to rotatewith respect to the vessel wall VW such that the visualization catheter370 can image and/or analyze 360 degrees of the vessel wall VW. Forexample, such a method can be advantageous for diagnostic purposesand/or for selecting a dissection location. Other suitable exemplarydevices, and systems, and methods for utilizing a visualization catheterfor diagnostic and/or dissection location purposes is described in U.S.patent application Ser. No. 14/498,969, filed Sep. 26, 2014, which isincorporated by reference herein in its entirety.

Once a treatment location is identified, the distal portion 300 can beadvanced to the treatment location, over the visualization catheter 370.Once at a location, the expandable element 326 can be expanded, causingthe vessel wall VW to conform around the opposite side of the catheter,as shown in FIG. 3A. At this point, the dissection assembly 380 can beadvanced distally through an exit port and into the vessel wall VW. Thedissection assembly 380 can include a tubular, beveled needle 382surrounded by a tubular support 384 having a tapered distal portion.Exemplary dissection assemblies can be found in any of the patentreferences incorporated herein, including U.S. Pat. No. 9,320,504, andincorporated herein by reference in its entirety. FIG. 3A shows anintermediate stage of a dissection procedure in which the needle 382 isbeing advanced within the vessel wall VW while ejecting fluid to createa sub-mural pocket SM within the vessel wall VW at a location that islongitudinally aligned with the trough 312. As such, during the walldissection, the visualization catheter 370 can be positioned within thetrough 312 such that the imaging portion 372 of the visualizationcatheter 370 is longitudinally aligned with at least a distal terminusof the needle 382. This way, a user can visualize the wall dissection.

In some embodiments, the transducer array 111 of FIGS. 1A-2C can becombined with the delivery catheter (and thus visualization catheter370) of FIGS. 3A-3B. Such a configuration can be beneficial forcapturing both close- and long-range images. For example, the transducerarray 111 can be configured to resolve images within a relatively closedistance (e.g., within about 1 mm to about 4 mm of the transducer array111), and the visualization catheter 370 can be configured to resolveimages at a relatively greater distance (e.g., about 4 mm to about 15 mmof the imaging device on the visualization catheter). The transducerarray 111 can include the same and/or different visualizationtransducers as the visualization catheter 370. For example, in aparticular embodiment, the visualization catheter 370 can be an IVUSdevice and the transducer array 111 can include OCT transducers (or viceversa). In yet other embodiments, the visualization catheter 370 can bean OCT device, and the transducer array 111 can include OCT transducers.In such embodiments, the optical transducers of the visualizationcatheter 370 can be configured to transmit/receive a first wavelength,and the optical transducers of the transducer array 111 can beconfigured to receive a second wavelength different than the firstwavelength. Likewise, in those embodiments having an visualizationcatheter 370 and a transducer array 111 that includes ultrasoundtransducers, the ultrasound transducers of the visualization catheter370 can be configured to transmit/receive a first wavelength, and theultrasound transducers of the transducer array 111 can be configured toreceive a second wavelength different than the first wavelength.

In those embodiments utilizing short-range ultrasound imaging (eitherwith a visualization catheter or a transducer array), higher frequencytransducers may be used to gain resolution over short distances. In someembodiments, the frequency can be between about 20 Hz and about 200 Hz.In other embodiments, the frequency can be between about 30 Hz and about100 Hz. In yet other embodiments, the frequency can be between about 40Hz and about 80 Hz. In a particular embodiment, the frequency can bebetween about 45 Hz and about 60 Hz.

In some embodiments, it may be beneficial to provide the user with animage of the vessel wall VW and/or the delivery catheter (and/orassociated devices and systems) at the treatment site. The devices,systems, and methods of the present technology are configured togenerate both two-dimensional (2D) and three-dimensional (3D) images.The imaging techniques of the present technology provide for real-timediagnostic and procedural monitoring capabilities.

In some embodiments, a 3D image of a portion of treatment site can beconstructed with the 2D images gathered from the transducer array 111(FIGS. 1A-1D) and/or the visualization catheter 370 (FIGS. 3A-3B). Forexample, the controller can receive the imaging data and splice the 2Dimages together (and/or multiple 3D images), with standard averagingtechniques used to fill in areas of data overlap or locations where datais missing or shadowed. For example, FIG. 4A depicts a 360-degree, 3Dreconstruction of segment of a vessel V. In one embodiment, such a 3Dimage is obtained by imaging the treatment site with the visualizationcatheter 370 (FIGS. 3A-3B) while drawing the visualization catheter 370proximally from the distal configuration (or distally advancing thevisualization catheter 370 from the visualization lumen 371) at aconstant or predetermined speed. In some embodiments, one or moretransducers of the transducer array can be configured to move relativeto the delivery catheter (e.g., rotate, pivot, translate, etc.) and thuscan also obtain such a “sweeping” shot. In some embodiments, an array ortransducers (for example, as shown in FIG. 1D), can be automaticallyactivated to send and receive signals at different specified times, atthe same time (once and/or on a repeated schedule) to generate a static,dynamic, or real-time dynamic 3D image(s). Although the 3D image in FIG.4A shows the exterior of the vessel, in other embodiments the 3D imagecan include all or a portion of the interior of the vessel or vesselwall. For example, as depicted schematically in FIG. 4B, the controllercan combine 2D plane images 412 to create a 3D image 410 of the portionof the vessel wall targeted for, undergoing, or already completeddissection. It will be appreciated that the width of the portioncorresponds to the width of the trough channel 113 (FIGS. 1A-1D) (e.g.,the distance between the sidewalls 109 at the tissue engaging portions114).

In some embodiments, the handle and/or display can be configured suchthat a user can toggle between desired 2D and 3D views, display one ormore views simultaneously, scan across one or more views, zoom in/out ona particular feature, and/or rotate the 3D images. In a particularembodiment, the controller can include one or more algorithms that cananalyze the 2D or 3D image, for example, by using patterns stored in thecontroller memory and associating certain patterns with certain knownanatomical and/or device structures. The controller can then identifyfeatures of potential interest and provide an overlay on the image(e.g., as shown on the display) that provides additional informationand/or clarification of the image. For example, as shown in FIG. 4C, theoverlay may highlight certain scarring or fibrosis 402 present in thetissue, the presence of collateral vessels 404, and/or other anatomicfeatures important to the particular diagnostic or procedure. In someembodiments, the overlay can identify different layers within the vesselwall, such as intima, media and adventitia. The overlay can callattention to various features using color coding, identifying symbols(e.g., arrows, circled portions, elevation lines, etc.), text, and/ornumbers. Moreover, the overlay can include a length scale 408. Forexample, the length scale can be positioned along the axis of thedisplayed vessel. Similar overlays may also depict distances betweenfeatures and/or the estimated size of particular features of interest.

In some embodiments, the overlay can include a “phantom valve” 406 (FIG.4C) outline. In some embodiments, the user can choose the location of aphantom valve via a user interface (not shown), and that location may bedisplayed to the user with a text depiction 409. This location can thenbe stored in the memory such that, when the delivery catheter isdelivered to the general vicinity of the treatment site, the controllercan alert the user (e.g., via the display) as to where the deliverycatheter should be positioned so as to be aligned with the phantomvalve. For example, the controller can include an algorithm thatanalyzes the images and stores the locations of certain anatomicallandmarks near the phantom valve site in the memory, as well as eachlandmark's location relative to the phantom valve site. In a particularembodiment, the controller can monitor the position of the deliverycatheter (and/or components thereof) and compare that position to theposition of the visualization catheter when imaging a desired treatmentlocation. In other embodiments, the controller can indicate where toposition the delivery catheter based on manual input from the user usingstandard sheath and catheter marking systems).

In any of the embodiments disclosed herein, it may be advantageous forautomatic tracking of one or more imaging planes at the treatment site.FIG. 5 shows an embodiment in which the controller can activate (e.g.,automatically or manually) one or more transducer(s) of the transducerarray 111 at the same or different times to obtain images of differentplanes. For example, as shown in FIG. 5, the transducer array can imageplane A at a first time, which can include the needle 502. Additionallyor alternatively, the controller can activate the transducer(s) to imageplane B at a second time, which can be distal to the needle 502 (e.g.,to monitor a developing hydrodissection pocket 505 within the vesselwall VW). The first time and the second time can be the same time ordifferent times. In some embodiments, the controller can display bothplane A and plane B simultaneously. For example, the display can showplane A and plane B side-by-side. In a particular embodiment, thecontroller can automatically toggle between plane A and plane B. It willbe appreciated that any number of planes can be imaged and/or displayed.In some embodiments, the controller can determine which plane to displaybased on the position of the needle 382 (FIGS. 3A-3B), for example, byutilizing algorithms and/or any number of distance-tracking devicesbuilt into the back end of the delivery catheter. In one embodiment, thecontroller can select which plane(s) to display based on patternrecognition. For example, it is known that a metal needle reflects moresound or light waves than does tissue, and the controller can include analgorithm that detects an image having bright spots (created by thereflection of the metal needle), label that image as the referenceframe, and choose an imaging plane (and/or move the visualizationcatheter, transducer, and/or delivery catheter) relative to thereference frame location.

Although FIG. 5 shows the transducer array 111 performing selectiveactivation of transducers to image various planes of view, thevisualization catheter 370 can additionally or alternatively be used.For example, the visualization catheter 370 can be coupled to anactuator (not shown) (e.g., at the proximal portion of the deliverycatheter) which can be configured to advance or retract thevisualization catheter 370 to desired locations at the treatment site.In some embodiments, the desired locations can be determined manually orautomatically during the procedure, and in some embodiments the desiredlocations can be on a predetermined schedule.

In some embodiments, it may be beneficial to position an imaging device(e.g., a transducer) on the needle 382 and/or the dissection assembly380 (FIGS. 3A-3B) such that the imaging is fully contained on the needle382 (transmitting and receiving). In other embodiments, the transmissioncan occur at the needle 382, and the reception can occur at thedissection assembly 380. The imaging device can have other positions.For example, FIG. 6A is a top view of a pocket creation element 602(e.g., a balloon, a wire cage, etc.) having an elongated shaft 603, anexpandable element 605 coupled to the elongated shaft 603, and aplurality of imaging devices 600 positioned around the circumference ofthe elongated shaft 603. In FIG. 6A, the expandable element 605 is shownin an expanded, partially straightened configuration for ease ofillustration. At least when the expandable element 605 is expanded, theimaging devices 600 can be positioned within the expandable element 605.As shown in the non-straightened end view of the pocket creation element602 in FIG. 6B, the pocket creation element 602 can imitate thecurvature of the vessel wall (not shown). In those embodiments where theexpandable element 605 is a balloon, the material of the balloon can beselected to reduce scattering or reflections of the imaging wave. Forexample, the balloon can be inflated with saline, and all air bubblescan be removed from the inflation line.

III. CONCLUSION

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theexampled invention. Accordingly, it is to be understood that thedrawings and descriptions herein are proffered by way of example tofacilitate comprehension of the invention and should not be construed tolimit the scope thereof.

From the foregoing, it will be appreciated that specific embodiments ofthe invention have been described herein for purposes of illustration,but that various modifications may be made without deviating from thescope of the invention. Accordingly, the invention is not limited exceptas by the appended claims.

1-19. (canceled)
 20. A system, comprising: a delivery catheterconfigured to be intravascularly delivered to a dissection site within ablood vessel, the delivery catheter comprising a device lumen, avisualization lumen, and an open trough having a channel; a dissectionassembly having a distal terminus, wherein the dissection assembly isconfigured to extend through the device lumen of the delivery catheter;and wherein— the visualization lumen is configured to receive avisualization catheter having a distal end portion with an imagingportion, the channel of the open trough is configured to allow theimaging portion to generate images of portions of a length of the vesselwhen the imaging portion is aligned with the channel during walldissection.
 21. The system of claim 20 wherein the distal terminus ofthe dissection assembly comprises a beveled needle, wherein the beveledneedle and the imaging portion are configured to be in longitudinalalignment during wall dissection.
 22. The system of claim 20, furthercomprising an actuator coupled to the visualization catheter andconfigured to be activated to automatically move the visualizationcatheter through the channel to predetermined locations during walldissection.
 23. The system of claim 20 wherein: the dissection assemblycomprises a needle configured to eject fluid to create a sub-muralpocket within the vessel wall and further configured to be advancedwithin a vessel wall while ejecting fluid; and the imaging portion ofthe visualization catheter configured to be longitudinally aligned withthe needle during wall dissection.
 24. The system of claim 20 whereinthe vizualization lumen and the trough are configured to allow thevisualization catheter to move longitudinally beyond a distal terminusof the trough to a position outside of the visualization lumen.
 25. Asystem for visualization of intravascular creation of autologous valves,the system comprising: a delivery catheter having a distal portionconfigured to be intravascularly advanced to a dissection site within avessel, wherein the distal portion comprises— an open trough including achannel; a visualization lumen extending through the channel andconfigured to receive a visualization catheter having imaging portionfor generating images of portions of a length of the vessel while thevisualization catheter moves through the channel; and a device lumenhaving an exit port; and a dissection assembly configured to be advancedthrough the device lumen, wherein— a distal terminus of the dissectionassembly is configured to extend beyond the exit port into a vessel wallof the vessel and further configured to create a sub-mural pocket withinthe vessel wall, and the imaging portion of the visualization catheterand the distal terminus of the dissection assembly are configured to bemoved into longitudinal alignment with each other as the dissectionassembly is advanced into the vessel wall during creation of thesub-mural pocket.
 26. The system of claim 25 wherein the channel of thetrough comprises an enclosed visualization lumen configured to receivethe imaging portion of the visualization catheter as the imaging portionis distally advanced through the enclosed visualization lumen.
 27. Thesystem of claim 26 wherein the trough is configured to allow the imagingportion of the visualization catheter to move beyond a distal terminusof the trough to a position outside of the enclosed visualization lumen.28. The system of claim 25 wherein the visualization lumen is configuredto receive a guidewire before receiving the visualization catheter. 29.A system, comprising: a delivery catheter configured to beintravascularly delivered to a dissection site within a blood vessel,the delivery catheter comprising a device lumen, a visualization lumen,and an open trough having a channel; a dissection assembly having adistal terminus, wherein the dissection assembly is configured to extendthrough the device lumen of the delivery catheter; and a visualizationcatheter having a distal end portion with an imaging portion, wherein—the visualization catheter is configured to extend through thevisualization lumen and through the channel of the open trough, theimaging portion is configured to generate images of portions of a lengthof the vessel while the imaging portion is aligned with the channel ofthe open trough, and the imaging portion is further configured to bepositioned into longitudinal alignment with the dissection assemblyduring wall dissection.